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FDA 510(k) Application Details - K223433
Device Classification Name
More FDA Info for this Device
510(K) Number
K223433
Device Name
Quantra QPlus System
Applicant
HemoSonics, LLC
4020 Stirrup Creek Drive, Suite 105
Durham, NC 27703 US
Other 510(k) Applications for this Company
Contact
Deborah Winegar
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QFR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/14/2022
Decision Date
12/13/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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